Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting.

Patients' global assessments for overall treatment outcomes will be measured by a single item with a 5-point Likert scale question (much improved, somewhat improved, the same as baseline, somewhat worsened, much worsened)

Use of rescue medication in the ED [ Time Frame: at ED discharge (within 3 hours from ED admission) ] [ Designated as safety issue: No ]

Use of additional rescue medication for relieving pain will be measured by electronic medical charts

Use of additional medication or healthcare resources [ Time Frame: 72 hours after the ED discharge ] [ Designated as safety issue: No ]

Use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured by patients' self-reports via telephone interviews.

Length of stay in the ED [ Time Frame: at ED discharge (within 3 hours from ED admission) ] [ Designated as safety issue: No ]

Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.

Proportion of treatment responder is defined as patients who have experienced at least a 50% reduction in pain intensity from baseline values; these values will be calculated using the pain intensity VAS scores.

All expected or unexpected adverse events in both groups will be measured during the allocated intervention process and during the entire follow-up period. Types and frequency of occurrences of adverse events will be measured.

Participant-perceived acceptability of acupuncture treatment will be measured by a single item with a 5-point Likert scale question (acupuncture was very helpful, somewhat helpful, don't know, somewhat not helpful, very not helpful).

Radiographic and physical examinations to exclude fractures or other serious conditions will be performed for all patients before considering eligibility in the study. After completion of the examination, patients who have pain of at least a level 4, as measured by the Wong-Baker scale (ranges 0 to 10), will receive intravenous or intramuscular injections of non-steroidal anti-inflammatory drugs (NSAIDs) for immediate pain control. All patients will be observed 30 minutes after the administration of the NSAIDs. In patients with primary headaches who respond poorly to the initial NSAID injection, an intravenous injection of opioid analgesics will be provided. After these initial standard ED management interventions, patients who are still suffering from acute pain will be asked to participate in the trial. During the study, rescue medication for immediate pain control will be allowed for patients allocated to both groups.

Procedure: Standard ED management alone

Experimental: Acupuncture plus standard ED management

The patients in this group will receive a single session of individualized acupuncture treatment delivered by a certified Korean Medicine Doctor (KMD) specialized (or in-training) in acupuncture and moxibustion medicine and with at least 3 years of clinical experience. The acupuncture formulas will be composed based on the individual patient's symptoms and at the KMD's discretion. Acupuncture treatments will be provided in line with standard ED management, the same as in the control group.

Procedure: Acupuncture plus standard ED management

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation

Acute neck pain with no evidence of neurological abnormality

Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4)

Acute ankle injury with no evidence of fracture or complete tear of ligaments

Exclusion Criteria:

Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain

Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition

Pain due to bone fracture or joint dislocation

Pain with fever (defined by a temperature above 37.5 °C)

Inappropriate at the ED physician's discretion

Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management

Pregnant women

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013908